Delpharm Reims SAS

Primary objective To evaluate the pharmacokinetic characteristics (PK) of lanifibranor after single and multiple administrations in healthy Chinese adult subjects. Secondary objective To evaluate the safety of lanifibranor after single and multiple administrations in healthy Chinese adult subjects.

This Phase III study is designed to evaluate lanifibranor in adult subjects with NASH and fibrosis. The primary objectives of the two periods of the main cohort are: Double-blind placebo-controlled (DBPC) period (Part A) To evaluate the effect of lanifibranor compared with placebo in achieving NASH remission and improvement in fibrosis assessed by liver histology. Double-blind investigational extension (ATE) treatment period (Part B) To evaluate the safety of lanifibranor after the DBPC period.